QA Investigation Results

Pennsylvania Department of Health
PLANNED PARENTHOOD OF SOUTHEASTERN PA
Health Inspection Results
PLANNED PARENTHOOD OF SOUTHEASTERN PA
Health Inspection Results For:


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Initial Comments:

This report is the result of a registration survey completed on June 1, 2012, at the Planned Parenthood of Southeastern Pennsylvania in Norristown. It was determined that the facility was in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.






Plan of Correction:




Initial Comments:

This report is the result of an unannounced on-site pre-licensure and occupancy survey completed on June 1, 2012, at Planned Parenthood of Southeastern PA- Norristown. Based on the survey it was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.





Plan of Correction:




551.22 (a)(4) LICENSURE
Criteria for Performance of Pediatric Patient

Name - Component - 00
551.22. Criteria for Performance of Ambulatory Surgery on Pediatric Patients

(a) In addition to the criteria set forth at 551.21 (relating to criteria for ambulatory surgery), the following criteria shall apply to the performance of ambulatory surgery on children under 18 years of age.
(4) A medical professional who has successfully completed a course in advanced pediatric life support offered by the American Academy of Pediatrics and either the American College of Emergency Physicians or the American Heart Association shall be present in the facility.

Observations:

Based on a review of Facility Documents, credential files (CF), personnel files (PF), and interview with staff (EMP), it was determined that the facility failed to provide staff trained in Pediatric Advanced Life Support (PALS) for surgical procedures performed on children under 18 years of age.

Findings include:

A request was made to EMP1 on May 31, 2012, for a list of patient's under the age of 18 who had abortion services provided at the facility from June 1, 2011, to May 31, 2012. EMP1 provided a list, that revealed 77 patient's under the age of 18 received abortion services from June 1, 2011, to May 31, 2012.

A review on May 31, 2012, of the facility's CF's and PF's revealed that none of the physicians and nurses employed by the facility had completed a course in PALS.

An interview with EMP1 on June 1, 2012, at approximately 2:10 PM confirmed the facility had seen 77 pediatric abortion patient's and intended to care for pediatric surgical abortion patient's in the future and EMP1 confirmed that none of the physicians and nurses employed by the facility had completed a course in PALS.












Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an abulatory surgical facility.


553.3 (5)(i)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(5) Adopting bylaws or similar rules and regulations for the orderly development and management of the ASF, which:
(i) Describe the authority delegated to the person in charge and to the medical staff.
(ii) Require the governing body to review and approve the bylaws, or similar rules and regulations, of the medical staff.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the governing body failed to approve the bylaws, or similar rules and regulations, of the medical staff.

Findings include:

A request was made to EMP1 and EMP3 on May 31, 2012, for Medical Staff Bylaws or similar rules and regulations, approved by the governing body. No documents were provided.

An interview with EMP1 and EMP3 on May 31, 2012, at approximately 3:10 PM confirmed the facility did not have documented evidence of Medical Staff Bylaws approved by the governing body.













Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an abulatory surgical facility.


553.3 (8) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:


Observations:

Based on review of the Child Protective Services Law, facility documents, personnel files (PF) and interview with staff (EMP), it was determined the facility failed to ensure processes were in place to meet the requirements for background checks as required by Act 179 of 2006 and Act 73 of 2007.

Findings include:

"The Child Protective Services Law (CPSL), 23 Pa.C.S. 6344.2 and 6344(b) requires that employees hired after July 1, 2008, who have a significant likelihood of regular contact with children in the form of care, guidance, supervision or training must obtain three background checks as condition of employment. Pennsylvania State Police Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check."

A review on June 1, 2012, of personnel files revealed no documentation that three background checks were conducted for any of the employees.

An interview conducted on June 1, at 2:00 PM with EMP1 confirmed that the facility performs surgery on pediatric patients and that there was no documentation that all three background checks were conducted on any of the employees.




Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


553.3 (8)(iii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(iii) Personnel records shall include current information relative to periodic work performance evaluations.



Observations:

Based on review of facility policy and procedures, personnel files (PF), and interview with staff (EMP), it was determined that the facility failed to ensure that employee performance appraisals were completed annually for three of six personnel files reviewed (PF1, PF2, PF3).

Findings include:

A review of facility policy "309 Performance Evaluation," dated revised July 1, 2009, revealed "...Performance evaluations are scheduled approximately every 12 months..."

A review of PF1, PF2 and PF3, revealed the employees performance evaluations were not completed within the past 12 months.

An interview with EMP1 on June 1, 2012, confirmed that PF1, PF2 and PF3, performance evaluations were not completed within the past 12 months per facility policy.













Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


555.3 (e) LICENSURE
Requirements

Name - Component - 00
555.3 Requirements for membership and privileges

(e) Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.

Observations:

Based on review of facility credential files (CF), and interview with staff (EMP), it was determined that the facility failed to ensure that all members of the medical staff were appointed at regular intervals no longer than every two years for 2 of 2 credential files reviewed. (CF1 and CF2).

Findings include:

A review on May 31, 2012, of CF1 and CF2, revealed no documented evidence the physicians were appointed to the medical staff at regular intervals no longer than every two years.

An interview conducted on May 31, 2012, at approximately 3:00 PM with EMP3 confirmed that CF1 and CF2, revealed no documented evidence the physicians were appointed to the medical staff at regular intervals no longer than every two years.












Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


555.23 (f) LICENSURE
Surgical Services - Operative Care

Name - Component - 00
555.23 Operative Care

(f) There shall be a written agreement in effect with an ambulance service staffed by certified EMT personnel, for the safe transfer of a patient to a hospital in an emergency situation, or as the need arises.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to have a written agreement with an ambulance service.

Findings include:

A review on May 31, 2012, of the facility's contract documents revealed that the facility did not have a contract or written agreement with an ambulance service.

An interview conducted on June 1, 2012, at approximately 10:45 AM with EMP1, confirmed the facility did not have a written agreement or contract with an ambulance service.










Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


555.31 (a) LICENSURE
ANESTHESIA SERVICES - Principle

Name - Component - 00
Anesthesia Services

555.31 Principle
(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF licence.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined that the facility failed to provide documented evidence of facility physician's appointed to the medical staff with clinical privileges to administer anesthesia.

Findings include:

A review of the Pennsylvania Department of Health's response to Planned Parenthood Southeastern Pennsylvania exception requests, dated April 20, 2012, revealed "...28 Pa. Code 555.3 (Definitions). Norristown Health Center indicates that it wants to use Propofol...The Exceptions Committee grants your request, on the condition that the Norristown Health Center's self-imposed conditions are implemented..."

A request was made to EMP1 and EMP3 on May 31, 2012, for documented evidence of facility physician's appointed to the medical staff with clinical privileges to administer anesthesia. EMP1 confirmed on June 1, 2012, at approximately 2:20 PM that the facility did not have physician's appointed to the medical staff with clinical privileges to administer anesthesia. Further, EMP1 confirmed that the facility did not have a contract for Anesthesia services to be provided at the facility.


























Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


555.33 (d)(8)(i-v) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) level of activity
(ii) respirations
(iii) blood pressure
(iv) level of consciousness
(v) oxygen saturation by pulse oximetry.

Observations:

Based on observation and interview with staff (EMP), it was determined the facility failed to provide patient monitoring equipment to include oxygen saturation by pulse oximetry.

Findings include:

An observation tour conducted on May 31, 2012, of the facility's intended Operating room "Exam Room 5" and recovery room revealed there was no patient monitoring equipment to include oxygen saturation by pulse oximetry.

An interview conducted on May 31, 2012, at 11:30 AM with EMP1 confirmed there was no patient monitoring equipment to include oxygen saturation by pulse oximetry.












Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


561.25 LICENSURE
Distressed drugs, devices and cosmetics

Name - Component - 00
561.25 Distressed drugs, devices and cosmetics

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.


Observations:

Based on review of facility policy and procedures, review of facility documents, and interviews with staff (EMP), it was determined the facility failed to ensure proper disposal of expired medications.

Findings include:

1) A review of facility policy "Pharmaceutical Services," dated December 2011, revealed "I. Pharmaceutical Services...1. Medical Director - is responsible for developing policies and procedures for pharmaceuticals that must include...inspection of all drug storage areas to remove expired drugs..."

2) An observation tour on May 31, 2012, of the facility's storage cabinets located in the hallway where the facility's exam rooms are located revealed the following expired products: two bottles of doxycycline hyclate 100 mg capsules, that were marked expired; and three containers of Terconazole Vaginal cream, that were marked expired.

An interview with EMP1 on May 31, 2012, at approximately 10:10 AM confirmed the above medications were expired.
__________________________________

1) An observation tour of Exam Room four on May 31, 2012, revealed two bottles labeled Saline, that were marked expired.

An interview with EMP1 on May 31, 2012, at approximately 10:40 AM confirmed the above bottles of Saline were marked expired.
____________________________________

1) An observation tour of the facility's patient check out area on May 31, 2012 revealed a drug storage closet that contained 10 boxes of Activella, where each box contained 10 tablets, and each box was marked expired.

An interview with EMP1 on May 31, 2012, at approximately 11:50 AM confirmed the above boxes of Activella were marked expired.








Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

Name - Component - 00
567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.


Observations:

Based on a review of facility policy, an observation tour, and interview with staff (EMP), it was determined that the Center failed provide a functional and sanitary environment for the provision of surgical services

Findings include:

1) A review of the facility's Infection Control policy and procedure manual dated June 2010 revealed "...VIII. Disinfection and Sterilization of Instruments / Preparation of Instruments for Shipping / Servicing...B. Procedure for preparation of critical and semi-critical items for sterilization / disinfection...5. Sterilize brushes, used for cleaning instruments, once weekly..."

2) An observation tour conducted on May 31, 2012, of the facility's combined Clean Workroom / Soiled Workroom revealed two brushes used for cleaning instruments each one stored on the side of the two sinks.

3) A review of the facility's Lab Binder June 1, 2012, revealed no documented evidence that the brushes used for cleaning instruments were sterilized weekly per facility policy.

An interview with EMP2 on June 1, 2012, at approximately 1:15 PM confirmed that facility's Lab Binder revealed no documented evidence that the brushes used for cleaning instruments were sterilized weekly per facility policy.












Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.2 (2)(ii) LICENSURE
Committee Responsibilities

Name - Component - 00
567.2 Committee responsibilities

The quality assurance committee shall be responsible for:
(2) The designation of one full-time or one part-time employee
responsible for developing and monitoring the infection control
program including, but not limited to:
(ii) Procedures and techniques for meeting established sanitation and
asepsis standards.


Observations:

Based on Observation tours, review of facility documents, and staff interview (EMP), it was determined that the facility failed to maintain established sanitation and asepsis standards.

Findings include:

1) A request was made to EMP2 on June 1, 2012, for a facility policy related to the use of Organisol to soak instruments after patient use.

2) A review of the facility's Infection Control policy dated June 2010, revealed "...VIII. Disinfection and Sterilization of Instruments / Preparation of Instruments for Shipping / Servicing...B...1. Immediately after use, instruments should be completely submerged in Alconox..."

3) Observation tours conducted on May 31, 2012, at approximately 9:30 AM of the facility's Exam Room's one through Exam Room five revealed each room contained a bucket filled with a solution called Organisol to soak instruments after patient use.

An interview with EMP2 on on June 1, 2012, at approximately 1:30 PM confirmed that the facility's policy referenced the use of Alconox and not Organisol. EMP2 confirmed that the facility did not have a policy for the use of Organisol.








Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.3 (b)(3) LICENSURE
Policies and Procedures

Name - Component - 00
567.3 Policies and procedures

(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(3) Sterilization and disinfection, including suitable equipment for routine and rapid sterilization.

Observations:

Based on a review of facility documents, and staff interviews (EMP), it was determined that the facility did not adhere to professionally acceptable standards of practice for the sterilization and disinfection of equipment.

Findings include:

1) A review of the facility's sterilizer's manufacturers recommendations revealed "...Monitoring Loads...2. A biological spore test [Attest] indicator should be used weekly in a representative sterilizer load for sterilization assurance..."

2) A review of the facility's Laboratory policy and procedure manual dated May 2011 revealed "...IX. Laboratory and Clinic Equipment - Quality Control...Autoclave...Clean autoclave as per manufacturer's instructions. Document on Autoclave Log in Lab Binder...Attest indicators ar run monthly. Document on Autoclave Log in Lab Binder..."

3) A review of the facility's "Attest Monitoring Log," for January 2012 through May 2012 revealed the biological spore test [Attest] indicator were performed monthly.

An interview with EMP2 on June 1, 2012, at approximately 1:00 PM confirmed that the sterilizer's manufacturers recommendations revealed that the biological spore test [Attest] indicator are to be done weekly and the facility's policy stated monthly. Further EMP2 confirmed that per the facility's Attest Monitoring Log indicated that the facility was performing the the biological spore test [Attest] monthly.










Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.11 (1) LICENSURE
Operating suite equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size approprate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(1) Suitable surgical instruments customarily available for
the planned surgical procedure.


Observations:

Based on a review of facility policy, an observation tour, and interview with staff (EMP), it was determined that Center failed to provide suitable instruments customarily available for the planned procedure.

Findings include:

1) A review of the facility's Infection Control policy and procedure manual dated June 2010 revealed "...VIII. Disinfection and Sterilization of Instruments / Preparation of Instruments for Shipping / Servicing...B. Procedure for preparation of critical and semi-critical items for sterilization / disinfection...3. Instruments must be inspected for pitting or defects; if either of these are found the instrument the instrument should be sent for repair or replacement..."

2) An observation tour conducted on May 31, 2012, of the facility's combined Clean Workroom / Soiled Workroom revealed stored instruments, that were treated in the facility's sterilizer, and appeared to have areas of rust discoloration. The instruments included suture scissors, speculums and other instruments used for procedures.

An interview with EMP1 on May 31, 2012, at approximately 10:25 AM confirmed that the above mentioned stored instruments had areas of rust discoloration.



















Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.11 (2) LICENSURE
Operating Suite Equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size approprate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(2) Emergency call system

Observations:

Based on observation and interview with staff (EMP), it was determined the facility failed to provide an emergency call system in the operating room and recovery area.

Findings include:

1) An observation tour conducted on May 31, 2012, of the facility's intended Operating room "Exam Room 5" and recovery room revealed there were no emergency call systems located in these areas..

An interview conducted on May 31, 2012, at 11:30 AM with EMP1 confirmed there were no emergency call systems located in the intended operating room or recovery room.













Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.11 (5) LICENSURE
Operating Suite Equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size appropriate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(5) Cardiac monitor and defibrillator - required only if general anesthesia or intravenous sedation are used.


Observations:

Based on observation and interview with staff (EMP), it was determined the facility failed to provide a cardiac monitor and defibrillator.

Findings include:

1) An observation tour conducted on May 31, 2012, of the facility's intended Operating room "Exam Room 5" and recovery room revealed there were no cardiac monitors and defibrillators located in these areas..

An interview conducted on May 31, 2012, at 11:30 AM with EMP1 confirmed there were no cardiac monitors and defibrillators located in the facility.









Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.11 (7) LICENSURE
Operating Suite Equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size appropriate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(7) Tracheostomy and necessary pulmonary reexpansion supplies

Observations:

Based on observation and interview with staff (EMP), it was determined the facility failed to provide tracheostomy supplies for the operating room and recovery area.

Findings include:

1) An observation tour conducted on May 31, 2012, of the facility's intended Operating room "Exam Room 5" and recovery room revealed there were no tracheostomy supplies located in these areas..

An interview conducted on May 31, 2012, at 11:30 AM with EMP1 confirmed there were no tracheostomy supplies located in the Center.








Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


567.43 LICENSURE
Ventilation System

Name - Component - 00
The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).


Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure the ventilation system was inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply in critical areas of the facility.

Findings include:

1) A review on May 31, 2012, of facility documents revealed no policy regarding monitoring the temperature and humidity levels in the operating rooms and post anesthesia care unit.

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5"; and observation of the intended patient recovery room revealed the absence of monitoring devices for humidity.

An interview conducted on May 31, 2012, with EMP1 confirmed the facility did not have a policy for monitoring the temperature and humidity levels in the intended Operating room "Exam Room 5"; and the intended patient recovery room








Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.


571.1 LICENSURE
CHAPTER 571 - Construction Standards

Name - Component - 00
571.1 Minimum Standards

ASF construction shall be in accordance with the latest edition of the "Guidelines for Design and Construction of Hospital and Health Care Facilities," as published by the American Institute of Architects/Academy of Architecture for Health including those guidelines established for various outpatient facilities. In the alternative, a facility shall meet the construction guidelines for specified types of surgical procedures as listed in appendix A. Where renovation or replacement work is performed within an existing facility, all new work or additions shall comply with the requirements for new construction.

Observations:

Based on observation and interview with staff (EMP), it was determined the facility failed to ensure compliance with all applicable requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999 and the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities.

Findings include:

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-3.4.2.1 The recovery station shall be located in direct view of a nurse station.

2) Observation on May 31, 2012, of the intended patient recovery room revealed no nurse station.

Interview on May 31, 2012, with EMP1 confirmed the intended patient recovery room did not contain a nurse station that was in direct view of the patient recovery room.
________________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-3.4.2.2...Cubicle curtains or other provisions for privacy during post-operative care shall be provided.

2) Observation on May 31, 2012, of the intended patient recovery room area revealed no cubicle curtains for patient privacy.

Interview on May 31, 2012, with EMP1 confirmed the intended post-operative recovery room did not have cubicle curtains for privacy.
_______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-3.6 Support Areas for Operating Rooms...The following shall be immediately accessible to the operating room(s):...3.8-3.6.5 Scrub Facilities...3.8-3.6.5.1 Hands-free scrub station(s) shall be provided outside of but near the entrance to each operating room.

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed the Operating room had no Hands-free scrub station provided outside of but near the entrance to the intended Operating room.

Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" had no Hands-free scrub station provided outside of but near the entrance to the intended Operating room.
_______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-3.6.10 Soiled Storage / Workroom...A soiled handling / storage area, including provision for disposal of fluid waste, shall be provided.

2) Observation on May 31, 2012, Soiled Storage Room revealed a small closet that contained clean biohazard supplies and contained no provision for the disposal of fluid waste.

Interview on May 31, 2012, with EMP1 confirmed the Soiled Storage Room was a small closet that contained clean biohazard supplies and contained no provision for the disposal of fluid waste.
_______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities 3.8-3.6 Support Areas for Operating Rooms...The following shall be immediately accessible to the operating room (s):...3.8-3.7 Support Areas for Staff...A staff clothing change area shall be provided.

2) Observation of the intended Operating Room / Post Anesthesia Care Area revealed no staff clothing change area.

Interview on May 31, 2012, with EMP1 confirmed the Operating Room / Post Anesthesia Care Area revealed no staff clothing change area.
_______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-5.1.2.1...Soiled workroom. This room shall be physically separated from all other areas of the facility" and 3.8.-5.1.2.2 Clean/assembly workroom. Clean and soiled work areas shall be physically separated ... (2) This workroom shall have a hand-washing station. (3) This room shall contain appropriate and sufficient workspace and equipment for terminal sterilizing of medical and surgical equipment and supplies.

2) Observation of the facility on May 31, 2012, revealed the soiled work area and the clean work area were located together. The handwashing sinks in the soiled area were also designated to use for the clean area. The counter space located in the soiled area was also also designated to use for preparing of sterilized equipment.

Interview on May 31, 2012, with EMP1 confirmed the clean and soiled work areas shared the same space.
______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-5.1.2.3...Storage for clean/sterile supplies...(1) storage for packs, etc. shall include provisions for ventilation, humidity and temperature control.

2) Observation on May 31, 2012, of the combined clean workroom and soiled workroom revealed wrapped sterile supplies stored in cabinets within the same room. There were no temperature, humidity or ventilation monitors observed in this area where the sterile wrapped packages were stored.

Interview on May 31, 2012, with EMP1 confirmed the sterile supplies were stored in cabinets that were located in the physically combined clean and soiled work area and there was no provision to monitor temperature, humidity or ventilation in this area where sterile packages were kept.
_______________

1) Review of the Guidelines For Design and Construction of Health Care Facilities 2010 edition revealed "3.8 - 5.1.2.4 Soiled holding area...(2) Appropriate receptacles for biohazardous waste shall be provided, and these shall be placed in the designated soiled holding area."

2) Observation tour conducted on May 31, 2012, of Exam Rooms one through five, revealed each room contained wastebaskets for biohazard waste that were lined with red bags. Further, each exam room, contained a cardboard box, where the individual wastebasket red biohazard trash bags were stored.

An interview with EMP1 on May 31, 2012, at approximately 11:45 AM confirmed that each exam room, contained a cardboard box, where the individual wastebasket red biohazard trash bags were stored.
_______________

1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-3.6.6 Drug Distribution Station Provision shall be made for storage and preparation of medication administered to patients.

2) Observation on May 31, 2012, of the combined clean workroom and soiled workroom revealed storage cabinets that contained numerous boxes of syringes and needles

3) Interview on May 31, 2012, with EMP1 confirmed that there was numerous boxes of syringes and needles stored in the combined clean and soiled work area.
_______________

A review of the Guidelines For Design and Construction of Health Care Facilities 2010 edition revealed "3.8 - 3.6.6.6 Drug Distribution Station...3.6.6.1 A refrigerator for pharmaceuticals and double-locked storage for controlled substances shall be provided."

1) An Observation tour of the facility's intended recovery room on May 31, 2012, revealed 62 bottles of Acetaminophen with Codeine that was not kept in double-locked storage.

An interview with EMP1 on May 31, 2012, at approximately 11:35 AM confirmed the facility did not have double-locked storage for controlled substances.
_______________

Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.7-3.3.4 Emergency Communication System All operating rooms shall be equipped with an emergency communication system designed and installed to effectively summon additional qualified staff support with no more than push activation of an emergency call switch."

1) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed there was no intercom system located in this room.

2) Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" contained no intercom system.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.7-3.3.5 Image Viewer...Each operating room shall have access to at least one medical image viewer located as required by the functional program.

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed there was no accessible image viewer.

Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" did not contain an accessible image viewer.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-7.2.2.2 Door openings ... (2) Toilet room doors for patient use shall open outward or be equipped with hardware that permits access from the outside in emergencies.

2) Observation on May 31, 2012, of the two patient restrooms located in the intended recovery room revealed the doors opened inwards. In addition the toilet room located within the waiting room and the toilet room located directly adjacent to the waiting room revealed the doors opened inwards.

Interview on May 31, 2012, with EMP1 confirmed the patient toilet room door's opened inwards and were not equipped with hardware that permits access from outside in emergencies.

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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 2.1 Common Elements for Hospitals...2.1-7.2.2.9 Grab bars...(1) Grab bars in all areas required to comply with the Americans with Disabilities Act shall comply with the Americans with Disabilities Act Guidelines...(2) Grab bars shall be provided in all patient toilets, showers, bathtubs, and sitz baths at a wall clearance of 1.5 inches (3.81 centimeters).

2) Observation on May 31, 2012, of one of the patient toilet room's located in the intended recovery room revealed the bathroom did not contain grab bars. In addition the toilet room located within the waiting room did not contain grab bars.

Interview on May 31, 2012, with EMP1 confirmed the above mentioned patient toilet room's did not contain grab bars.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.8-7.2.2.2 Door openings...(1) The minimum clear width of door openings for patient use shall be 2 feet 10 inches (86.36 centimeters) except that door openings requiring gurney / stretcher access (as defined by the functional program) shall have a nominal width of 3 feet 8 inches (1.11 meters).

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5"; observation of the intended patient recovery room; observation of the Front entrance and the rear entrance of the building revealed each door measured 35 inches and not 44 inches to allow for gurney / stretcher access.

Interview on May 31, 2012, with EMP1 confirmed the intended intended Operating room "Exam Room 5"; the intended patient recovery room; and the Front entrance and the rear entrance of the building door's each measured 35 inches and not 44 inches to allow for gurney / stretcher access.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, 3.7-3.3 Ambulatory Operating Rooms...3.7-3.3.3 Class B Operating Room..3.7-3.3.3.1 Space requirements. Class B operating rooms shall have a minimum clear floor area of 250 square feet (23.23 square meters) with a minimum clear dimension of 15 feet (4.57 meters).

2) Observation on June 1, 2012, of the intended Operating room "Exam Room 5" revealed the approximate square footage of the room was 15 feet by 13 feet which equaled approximately 195 square feet. Also, the room contained a desk and storage cabinets, which would make the clear dimension space lower than 195. The square footage with the desk and storage cabinets would be approximately 13.5 square feet by 11 square feet which equaled approximately 148.5 square feet.

Interview on June 1, 2012, with EMP2 confirmed the intended Operating room "Exam Room 5" approximate square footage was 195 without the desk and cabinets and 148.5 square feet with the desk and cabinets.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities Table 3.1 - 1 Station Outlets for Oxygen, Vacuum, and Medical Air in Outpatient Facilities....3.7 - 3.3.3...Class B-Surgical procedure with moderate sedation...Oxygen...2...Vacuum...2...3.7-3.4.2.2...Post-anesthesia recovery...Oxygen...1...Vacuum...1....

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed no oxygen and no vacuum. Further, the facility's intended Post-anesthesia Recovery Unit revealed no oxygen and no vacuum.

Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" contained no oxygen and no vacuum and the intended Post-anesthesia Recovery Unit contained no oxygen and no vacuum.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities 3.7-7.2.3.2 Flooring...(2) Vinyl composition tile (VCT) or similar products shall not be permitted in these areas...3.8.-7.2.33 Walls, wall bases, and wall protection...(1) Wall finishes in operating room (s) shall be scrubbable, able to withstand harsh chemical cleaning, and monolithic...(2) Wall bases in operating rooms and areas frequently subjected to wet cleaning shall be monolithic and coved directly up from the floor, tightly sealed to the wall, and constructed without voids.

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed the flooring was a vinyl composition tile or similar product and the wall bases were not monolithic and coved directly up from the floor.

Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" flooring was a vinyl composition tile or similar product and the wall bases were not monolithic and coved directly up from the floor.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities 3.7-7.2.3.4 Ceilings...(2) Restricted areas...(a) Ceilings in restricted areas such as operating rooms shall be monolithic, scrubbable, and capable of withstanding chemicals. Cracks or perforations in these ceilings are not allowed. (b) All access openings in ceilings in restricted areas shall be gasketed.

2) Observation on May 31, 2012, of the intended Operating room "Exam Room 5" revealed the ceiling was a paneled drop down ceiling, which was not monolithic, scrubbable, and capable of withstanding chemicals.

Interview on May 31, 2012, with EMP1 confirmed the intended Operating room "Exam Room 5" ceiling was a paneled drop down ceiling, which was not monolithic, scrubbable, and capable of withstanding chemicals.
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1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities 3.1 Common Elements for Outpatient Facilities...3.1-4.1 Laboratory Services...3.1-4.1.2.1 When lab tests are performed on site, a separate, dedicated room shall be provided.

2) Observation on May 31, 2012, of the hallway outside of the combined soiled workroom and clean workroom revealed a microscope for lab slide analysis located on a counter, where patient's walk past to enter the facility's exam rooms.

3) Observation on May 31, 2012, of the combined soiled workroom and clean workroom revealed a pass through window to a bathroom, where patient's place urine samples. Further observation of the same room revealed an open cart for blood and urine sample storage and a refrigerator for storage of lab supplies.

4) Observation of the facility's exam rooms revealed hemoglobin and RH type tests are conducted in the exam rooms.

Interview on May 31, 2012, with EMP1 confirmed the facility does not have a dedicated lab room.








Plan of Correction:

This site currently provides medication abortion only and we do not currently plan to offer surgical abortion going forward. We have therefore withdrawn our application to be an ambulatory surgical facility.